Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT00226434
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or over
* Positive HIV test result
* CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
* Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
* Naive to ART
* TB treatment started less than one week prior enrolment
* Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause)
* Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom.
Exclusion Criteria:
* Suspected TB with negative AFB
* Pregnant or breastfeeding women
* Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
* Unable and/or unlikely to comprehend and/or be adherent to the protocol
* Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00226434
Study Brief:
Protocol Section:
NCT00226434